Clinical Assessor

Clinical Assessment / 临床评审 

• Review and assess Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), and supporting clinical evidence. 
  评审临床评价报告（CER）、性能评价报告（PER）及相关支持性临床证据。 

• Evaluate the adequacy, scientific validity, relevance and consistency of clinical data supporting device safety, performance and clinical benefit. 
  评价支持产品安全性、性能及临床获益的临床数据是否充分、科学、相关且一致。 

• Critically appraise scientific publications, literature reviews, clinical investigation reports, performance study reports and post-market clinical evidence. 
  对科学文献、文献综述、临床试验报告、性能研究报告及上市后临床证据进行批判性评价。 

• Assess clinical benefit-risk conclusions and the alignment of clinical evidence with the device’s intended purpose, indications and target population. 
  评估临床获益风险结论，以及临床证据与产品预期用途、适应证和目标人群的一致性。 

• Identify gaps, deficiencies, inconsistencies and regulatory non-conformities in submitted documentation. 
  识别所提交文件中的缺口、不足、不一致及法规不符合项。 

Assessment Delivery and Collaboration / 评审交付与协作 

• Prepare clear, evidence-based, technically sound and timely assessment reports and conclusions. 
  编写清晰、基于证据、技术判断充分且及时的评审报告与结论。 

• Participate in multidisciplinary MDR/IVDR conformity assessment teams within the scope of assigned competence. 
  在获授权的能力范围内参与MDR/IVDR跨专业符合性评审团队工作。 

• Communicate assessment findings and requests for clarification effectively to internal stakeholders and customers, as applicable. 
  根据需要，向内部相关方及客户清晰沟通评审发现和补充资料要求。 

• Collaborate with relevant technical and clinical experts when specialist input is required. 
  需要专业意见时，与相关技术专家及临床专家协作。 

• Plan and manage assigned assessments to meet agreed quality and delivery expectations. 
  规划并管理所分配的评审工作，满足既定质量及交付要求。 

Competence and Continuous Improvement / 能力保持与持续改进 

• Maintain current knowledge of applicable medical device regulations, guidance documents, clinical research methods and relevant therapeutic developments. 
  持续掌握适用的医疗器械法规、指导文件、临床研究方法及相关治疗领域的发展动态。 

• Complete required training, qualification and competence maintenance activities. 
  完成岗位要求的培训、资格认定及能力保持活动。 

• Contribute to the improvement of assessment methods, templates and internal processes. 
  参与评审方法、模板及内部流程的持续改进。 

• Perform other reasonable duties assigned by the line manager. 
  完成直线经理安排的其他合理工作。